# Syneron Medical, Ltd.

- Location (FDA's records): Yokneam Illit, IL
- FDA decisions: 35 (2002–2017): 35 510(k) clearances
- Product codes: GEX (20), OHV (6), GEI (4), NUV (4), ONF (1)
- 510(k) review time since 2016: median 111 days, against 107 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 82 (33 its own); citations of its devices by later devices: 97 (33 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Thermage, Inc.: 6 (https://510kreport.com/company/thermage)
- Alma Lasers, Inc.: 5 (https://510kreport.com/company/alma-lasers)
- Palomar Medical Products, Inc.: 4 (https://510kreport.com/company/palomar-medical-products)
- Esc Medical Systems, Ltd.: 3 (https://510kreport.com/company/esc-medical-systems)
- Msq (M2), Ltd.: 3 (https://510kreport.com/company/msq-m2)
- Cynosure, Inc.: 2 (https://510kreport.com/company/cynosure)
- Lumenis, Inc.: 2 (https://510kreport.com/company/lumenis)
- Lhasa Medical, Inc.: 2 (https://510kreport.com/company/lhasa-medical)

## Firms that cite its devices most
- Syneron, Ltd.: 10 (https://510kreport.com/company/syneron)
- Cutera, Inc.: 6 (https://510kreport.com/company/cutera)
- Intermedic Arfran, SA: 6 (https://510kreport.com/company/intermedic-arfran)
- Alma Lasers, Inc.: 6 (https://510kreport.com/company/alma-lasers)
- Viora, Ltd.: 3 (https://510kreport.com/company/viora)
- Solta Medical, Inc.: 3 (https://510kreport.com/company/solta-medical)
- Sciton, Inc: 2 (https://510kreport.com/company/sciton)
- BTL Industries, Inc.: 2 (https://510kreport.com/company/btl-industries)

## Its most-cited devices
- K050397: Velasmooth, Shaper (2005), cited by 8
- K031671: Polaris WR (2003), cited by 8
- K071872: Velashape (2007), cited by 7
- K073572: Matrix RF Applicator (2008), cited by 5
- K163415: SlimShape System (2017), cited by 5
- K022266: Aurora SR (2002), cited by 5

## Recent decisions
- K170370: Ultrashape Power System (May 15, 2017)
- K163415: SlimShape System (Apr 20, 2017)
- K162163: UltraShape System (Nov 17, 2016)
- K161952: UltraShape System (Nov 7, 2016)
- K160896: Ultrashape Power System (Jul 8, 2016)
- K151655: CO2RE System (Sep 15, 2015)
- K141507: Two Skin Treatment System (Dec 8, 2014)
- K141708: Ultrashape System (Oct 6, 2014)

Source page: https://510kreport.com/company/syneron-medical